Topamate 100 mg (Topiramate)

Adult dose

It is advisable to start this medication at a low dose and increase it to the effective dose. Monitoring the blood concentration is not necessary to optimize treatment with this medication. The recommended dose of this medication applies equally to all adults and children, including older adults, in the absence of renal disease. It may be taken with or without food. The tablets should be swallowed whole without crushing. 1. Epilepsy 1) Monotherapy When discontinuing other concomitant antiepileptic drugs in order to administer topiramate as monotherapy, the potential effect on seizure control should be considered. Unless other antiepileptic drugs must be discontinued immediately for safety reasons, they should be tapered and discontinued gradually, by approximately 1/3 every 2 weeks (see “5. General Precautions” under Precautions for Use). When an enzyme-inducing drug is discontinued, topiramate concentrations may increase. If a clinically significant increase in topiramate concentration occurs, the dose of this medication may need to be reduced. Adults (17 years and older): Start with 25㎎ in the evening during the first week. Thereafter, increase the total daily dose by 25 or 50㎎ at 1-2-week intervals and administer it in 2 divided doses. If the patient has difficulty tolerating this titration schedule, the intervals between dose increases should be lengthened. The dose and rate of titration should be determined according to clinical response. The recommended dose for adult monotherapy is 100～200mg per day. The maximum recommended dose is 500㎎ per day. Some patients with recurrent epilepsy have tolerated topiramate monotherapy at doses up to 1,000㎎ per day. 2) Adjunctive therapy Adults (17 years and older) The minimum effective dose is 200mg per day, and the usual dose is 200-400mg per day in 2 divided doses. Depending on the patient, the dose may be increased to the maximum recommended dose of 800mg per day. Initiate treatment with 25-50mg in the evening during the first week; it is also possible to start at a lower dose. Thereafter, increase the dose by 25-50mg at 1-2-week intervals and administer it in 2 divided doses. If the patient has difficulty tolerating the increased dose, smaller increments may be used or the intervals between dose increases may be lengthened. The dose should be determined according to clinical effect. 2. Prevention of migraine Adults: Start with 25mg of this medication in the evening during the first week. Thereafter, increase the dose by 25mg/day at 1-week intervals. If the patient has difficulty tolerating these increases, lengthen the intervals between dose increases. The recommended dose is 100mg per day, administered in 2 divided doses. Some patients may respond to a dose of 50mg per day. Doses up to 200mg per day may be administered; the dose and rate of titration should be determined according to clinical response. 3. Patients with renal impairment - For patients with moderate or severe renal impairment (CLcr < 70 mL/min/1.73 m2), it is recommended that the initial and maintenance doses be reduced to approximately 1/2. - Patients on hemodialysis: Because this medication is removed from plasma by hemodialysis, the dose should be increased by approximately 1/2 on dialysis days. The dose should be increased taking into consideration the duration of dialysis, the clearance of the dialysis equipment, and the patient's residual renal clearance, and should be divided between the start and end of hemodialysis. 4. Patients with hepatic impairment This medication should be administered with caution to patients with hepatic impairment, as its clearance may be reduced.

Child dose

Children (6-16 years): Start with 0.5-1㎎/㎏ in the evening during the first week. Thereafter, increase the total daily dose by 0.5-1㎎/㎏ at 1-2-week intervals and administer it in 2 divided doses. If the patient has difficulty tolerating the increase, use smaller increments or lengthen the intervals between dose increases. The dose and extent of titration should be determined according to clinical response. The recommended dose for monotherapy in children is 3-6mg/kg per day. Doses up to 500㎎ per day have been used in children diagnosed with partial seizures. Children (2-16 years): The recommended daily dose is approximately 5-9mg/kg, administered in 2 divided doses. During the first week, administer 25mg (or less, based on 1-3mg/kg per day) in the evening. Thereafter, increase the total daily dose by 1-3mg/kg at 1-2-week intervals until an appropriate clinical effect is achieved, and administer it in 2 divided doses. Dose titration should be determined according to clinical effect. Doses up to 30mg/kg per day have been administered and were generally well tolerated.

This medication may increase the risk of suicidal thoughts or behaviors; therefore, if symptoms or mood changes occur during treatment, consultation with a physician should be sought immediately. Patients with epilepsy taking this medication may be at risk for sudden death, so regular monitoring is necessary. In rare cases, serious skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur, so if there are any changes to the skin, stop taking the medication immediately and inform medical personnel. Patients with allergies to any of the ingredients or lactose intolerance should not take this medication. Women who are pregnant or planning to become pregnant should take a pregnancy test before using this medication and should use effective contraception during treatment. Taking this medication during pregnancy may harm the fetus, so it should be used cautiously and only if necessary. Patients with impaired kidney or liver function may need dose adjustments, and those with kidney disease should ensure adequate hydration to reduce the risk of kidney stones. This medication can cause central nervous system side effects such as drowsiness, dizziness, and blurred vision; therefore, it is advisable to avoid driving or operating hazardous machinery during the initial stages of treatment. This medication may interact with other drugs, so patients should inform their doctor or pharmacist of any other medications they are taking. If there are changes in weight, mood changes, or symptoms of depression while taking this medication, consultation with medical personnel is necessary, and the medication should not be stopped abruptly but tapered off gradually. Proper hydration is important during the use of this medication, especially to prevent dehydration in hot weather or during exercise. Regular blood tests and status checks are necessary while taking this medication, and it is essential to inform medical personnel immediately if any abnormal symptoms occur.

Suicidal ideation, suicidal behavior, depression, abnormal changes in mood and behavior, sudden death, Stevens-Johnson syndrome, toxic epidermal necrolysis, sensory abnormality, hypereuphoria, ataxia, concentration disorder, attention deficit, confusion, dizziness, fatigue, paresthesia, somnolence, thought disorder, agitation, emotional instability, loss of appetite, asthenia, disorientation, memory impairment, diplopia, vertigo, speech disorder, vocabulary selection disorder, nausea, nystagmus, psychomotor retardation, tremor, visual disturbance, weight loss, gait disturbance, aggressive response, apathy, perceptual abnormality, discordance, leukopenia, psychiatric symptoms, dysgeusia, nephrolithiasis, thromboembolism, fatigue, asthenia, back pain, chest pain, influenza-like symptoms, limb pain, allergies, flushing, body odor, edema, rigidity, dizziness, ataxia, speech disorder, nystagmus, sensory abnormality, tremor, discordance, sensory loss, gait abnormality, involuntary muscle contraction, stupor, dizziness, nausea, indigestion, abdominal pain, constipation, gastroenteritis, thirst, gastrointestinal disorder, gingivitis, auditory abnormality, weight loss, myalgia, skeletal pain, epistaxis, purpura, hypereuphoria, psychomotor retardation, neuroirritability, memory impairment, disorientation, depression, concentration/attention deficit, loss of appetite, agitation, mood disorder, aggressive response, perceptual abnormality, decreased libido, apathy, depersonalization, emotional instability, breast pain, amenorrhea, menorrhagia, menstrual irregularities, prostate disorder, infection, viral infection, candidiasis, rhinitis, pharyngitis, sinusitis, dyspnea, erythematous rash, skin disorder, increased sweating, dysgeusia, urinary tract infection, hematuria, urinary incontinence, frequent urination, urinary abnormalities, diplopia, visual disturbances, ocular pain, leukopenia, anemia, vasodilation of the autonomic nervous system, fever, syncope, halitosis, abdominal distention, alcohol intolerance, substernal chest pain, sudden death, hypertension, hypotension, orthostatic hypotension, tension headache, erectile dysfunction, hallucinations, dysphoria, psychosis, psychomotor retardation, stupor, grand mal seizures, hyperactivity, leg cramps, reduced reflexes, neurosis, migraine, akinesia, sensory hypersensitivity, movement disorders, paradoxical reaction, speech disorder, scotoma, hypotonia, dystonia, coma, encephalopathy, fecal incontinence, insomnia, personality disorder, decreased libido, manic response, suicide attempt, paranoid response, increased appetite, delusion, paranoia, delirium, abnormal dreams, EEG abnormalities, cerebellar syndrome, tongue paralysis, increased libido, goiter, thyroid disorder, diarrhea, vomiting, hemorrhoids, flatulence, gastroenteritis, gingival hyperplasia, dental caries, stomatitis, dysphagia, melena, gastritis, hypersalivation, hiccups, gastroesophageal reflux, tongue swelling, esophagitis, belching, tinnitus, otalgia, auditory hypersensitivity, angina pectoris, palpitations, AV block bradycardia, complete heart block, arrhythmia, atrial arrhythmia, atrial fibrillation, elevated SGPT, elevated SGOT, gallbladder disorder, elevated γ-GT, dehydration, weight gain, thirst, hypokalemia, increased alkaline phosphatase, hypocalcemia, hyperlipidemia, acidosis, hyperglycemia, elevated creatinine, hyperchloremia, dry eye syndrome, diabetes, hypernatremia, abnormal serum folate, hyponatremia, hypocholesterolemia, hypoglycemia, hypophosphatemia, arthralgia, muscle weakness, arthropathy, osteoporosis, basal cell carcinoma, anemia, gum bleeding, thrombocytopenia, pulmonary embolism, lymphadenopathy, lymphadenitis, eosinophilia, lymphocytopenia, lymphocytosis, neutropenia, thrombocytosis, erythrocytosis, bone marrow suppression, pancytopenia, intermenstrual bleeding, leukorrhea, dysmenorrhea, vaginitis, amenorrhea, ejaculation disorder, lactation, cough, bronchitis, asthma, bronchial spasm, laryngospasm, acne, urticaria, alopecia, dermatitis, nail disorder, folliculitis, dry skin, eczema, skin depigmentation, psoriasis, photosensitivity reaction, erythematous rash, seborrheic dermatitis, decreased sweating, hair abnormalities, brown spots, dysgeusia, taste loss, aftertaste, dysuria, nephrolithiasis, urinary tract infection, frequent urination, urinary incontinence, urinary retention, facial edema, renal pain, nocturia, albuminuria, polyuria, oliguria, flushing, venous thrombosis, phlebitis, vascular rigidity, conjunctivitis, control abnormality, photophobia, lacrimation, strabismus, color blindness, myopia, dilation, cataract, corneal opacification, iritis, leukopenia, neutropenia, allergic edema, hyperammonemia, hyperammonemic encephalopathy, despair, sensorial anomalies of the eye, angle-closure glaucoma, conjunctival edema, eye movement disorders, eyelid edema, macular pathology, myopia, cough, chest discomfort, erythema multiforme, periorbital edema, peripheral edema, joint swelling, discomfort in limbs, renal tubular acidosis, renal calcinosis, systemic edema, influenza-like illness, weight gain, diaphoresis, exacerbation of epilepsy, mental disturbance, decreased sweating, elevated temperature, hyperammonemic encephalopathy, somnolence, vomiting, level of consciousness changes, cognitive function changes, vasodilation of the autonomic nervous system, fever, syncope, halitosis, abdominal distention, alcohol intolerance, substernal chest pain, sudden death, hypertension, hypotension, orthostatic hypotension, tension headache, erectile dysfunction, hallucinations, dysphoria, psychosis, psychomotor retardation, stupor, grand mal seizures, hyperactivity, leg cramps, reduced reflexes, neurosis, migraine, akinesia, sensory hypersensitivity, movement disorders, paradoxical reaction, speech disorder, scotoma, hypotonia, dystonia, coma, encephalopathy, fecal incontinence, insomnia, personality disorder, decreased libido, manic response, suicide attempt, paranoid response, increased appetite, delusion, paranoia, delirium, abnormal dreams, EEG abnormalities, cerebellar syndrome, tongue paralysis, increased libido, goiter, thyroid disorder, diarrhea, vomiting, hemorrhoids, flatulence, gastroenteritis, gingival hyperplasia, dental caries, stomatitis, dysphagia, melena, gastritis, hypersalivation, hiccups, gastroesophageal reflux, tongue swelling, esophagitis, belching, tinnitus, otalgia, auditory hypersensitivity, angina pectoris, palpitations, AV block bradycardia, complete heart block, arrhythmia, atrial arrhythmia, atrial fibrillation, elevated SGPT, elevated SGOT, gallbladder disorder, elevated γ-GT, dehydration, weight gain, thirst, hypokalemia, increased alkaline phosphatase, hypocalcemia, hyperlipidemia, acidosis, hyperglycemia, elevated creatinine, hyperchloremia, dry eye syndrome, diabetes, hypernatremia, abnormal serum folate, hyponatremia, hypocholesterolemia, hypoglycemia, hypophosphatemia, arthralgia, muscle weakness, arthropathy, osteoporosis, basal cell carcinoma, anemia, gum bleeding, thrombocytopenia, pulmonary embolism, lymphadenopathy, lymphadenitis, eosinophilia, lymphocytopenia, lymphocytosis, neutropenia, thrombocytosis, erythrocytosis, bone marrow suppression, pancytopenia, intermenstrual bleeding, leukorrhea, dysmenorrhea, vaginitis, amenorrhea, ejaculation disorder, lactation, cough, bronchitis, asthma, bronchial spasm, laryngospasm, acne, urticaria, alopecia, dermatitis, nail disorder, folliculitis, dry skin, eczema, skin depigmentation, psoriasis, photosensitivity reaction, erythematous rash, seborrheic dermatitis, decreased sweating, hair abnormalities, brown spots, dysgeusia, taste loss, aftertaste, dysuria, nephrolithiasis, urinary tract infection, frequent urination, urinary incontinence, urinary retention, facial edema, renal pain, nocturia, albuminuria, polyuria, oliguria, flushing, venous thrombosis, phlebitis, vascular rigidity, conjunctivitis, control abnormality, photophobia, lacrimation, strabismus, color blindness, myopia, dilation, cataract, corneal opacification, iritis, leukopenia, neutropenia, allergic edema, hyperammonemia, hyperammonemic encephalopathy, despair, sensorial anomalies of the eye, angle-closure glaucoma, conjunctival edema, eye movement disorders, eyelid edema, macular pathology, myopia, cough, chest discomfort, erythema multiforme, periorbital edema, peripheral edema, joint swelling, discomfort in limbs, renal tubular acidosis, renal calcinosis, systemic edema, influenza-like illness, weight gain, diaphoresis, exacerbation of epilepsy, mental disturbance, decreased sweating, elevated temperature, hyperammonemic encephalopathy, somnolence, vomiting, level of consciousness changes, cognitive function changes.

This medication should be stored in a tightly closed container to protect it from air and moisture. Additionally, it should be kept in a cool and dry place at temperatures below 25 degrees Celsius to maintain its efficacy.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 200 tablets/bottle